← Back to all trials
Completed
NCT04866134
A Study of ERAS-007 as Monotherapy or in Combination With ERAS-601 in Patients With Advanced or Metastatic Solid Tumors
Conditions: Advanced or Metastatic Solid Tumors
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 85
Sponsor: Erasca, Inc.
Location: Sarah Cannon Research Institute (HealthONE) Denver Colorado
Summary
* To evaluate the safety and tolerability of ERAS-007 monotherapy administered once weekly (QW) and twice daily-once weekly (BID-QW).
* To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007 monotherapy administered BID-QW.
* To characterize the pharmacokinetic (PK) profile of ERAS-007 monotherapy.
* To determine the optimal dose and schedule of ERAS-007 monotherapy.
* To evaluate antitumor activity of ERAS-007 in various solid tumors.
* To evaluate the safety and tolerability of ERAS-007 (BID-QW) and ERAS-601 (twice daily for three weeks on and 1 week off (BID 3/1)) when administered in combination.
* To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007 administered in combination with ERAS-601.
* To characterize the pharmacokinetic (PK) profile of ERAS-007 and ERAS-601 when administered in combination.
* To evaluate antitumor activity of ERAS-007 and ERAS-601 when administered in combination in various solid tumors
* To evaluate antitumor activity of ERAS-007 and ERAS-601 when administered in combination in various solid tumors
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 years.
* Willing and able to give written informed consent.
* Have histologically or cytologically confirmed advanced or metastatic solid tumor with a relevant molecular alteration (as applicable).
* There is no available standard systemic therapy available for the patient's tumor histology and/or molecular biomarker profile; or standard therapy is intolerable, not effective, or not accessible; or patient has refused standard therapy.
* Recovered from all toxicities associated with prior treatment to acceptable baseline status.
* Have ECOG performance status of 0 or 1 with an anticipated life expectancy of \> 12 weeks.
* Willing to comply with all protocol-required visits, assessments, and procedures.
* Able to swallow oral medication.
Exclusion Criteria:
* Currently receiving another study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of ERAS-007.
* Received previous treatment with an ERK inhibitor.
* For participants being considered for ERAS-007 + ERAS-601 (Part D): prior treatment with SHP2 inhibitor.
* For participants being considered for ERAS-007 + ERAS-601 (Part D): documented PTPN11 mutations
* Received prior antineoplastic therapy within \< 21 days or 5 half-lives, whichever is shorter.
* Received prior palliative radiation within 7 days of first dose of ERAS 007 or ERAS-601,
* Received previous treatment with a MAPK inhibitor that resulted in discontinuation due to unacceptable toxicity.
* Prior surgery (e.g., gastric bypass surgery, gastrectomy) or gastrointestinal dysfunction (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) that may affect drug absorption.
* Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs.
* Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial.
Source: ClinicalTrials.gov (NCT04866134). StuddyBuddy aggregates publicly available trial information.